Z-2334-2008

ZOLL OneStep Multi-Function Electrode; Adult Complete Part #: 8900-0214-01. The electrodes are indicated for...

Name: Z-2334-2008 ZOLL OneStep Multi-Function Electrode; Adult Complete Part #: 8900-0214-01. The electrodes are indicated for...
Creator: Bio-Detek, Inc.
Published: 2008-06-16
License: https://open.fda.gov/license/

ZOLL Medical Corporation / initiated 2008-06-16 / Terminated / root cause: manufacturing process

FDA source

Bio-Detek, Inc. began a recall of ZOLL OneStep Multi-Function Electrode; Adult Complete Part #: 8900-0214-01. The electrodes are indicated for the following clinical applications... on 2008-06-16. The reason FDA records is "Multi-function electrode programmed as a Pediatric instead of Adult". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2334-2008
Status: Terminated
Initiated: 2008-06-16
Posted: 2008-09-20
Terminated: 2016-05-10
Recalling firm: ZOLL Medical Corporation
Product: ZOLL OneStep Multi-Function Electrode; Adult Complete Part #: 8900-0214-01. The electrodes are indicated for the following clinical applications: Defibrillation, Cardioversion, Noninvasive pacing, and Electrocardiograph monitoring.
Product code: MLN Electrode, Electrocardiograph, Multi-Function
Reason for recall: Multi-function electrode programmed as a Pediatric instead of Adult
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Bio-Deteck notified the own label distributor and in cooperation the firm notified their customers by letter dated 6/16/08. Users are requested to return the lots and replacement product will be provided. Zoll issued and Urgent Device Correction letter on June 16, 2008 with instructions to follow if the device is used with the defective electrodes. If you have questions, contact ZOLL Medical Technical Service at 1-800-348-9011.
Quantity in commerce: 25 cases of 8/cs for each lot # ; Total of 400 units
Distribution: MA
Product codes and lots: Lot #'s : 2108 & 2208

Product code MLN

K051076Class IIIZoll Stat*padz Mwp Multi-Function ElectrodesZOLL Medical Corporation / cleared 2005-05-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)